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 August 3, 2010 - 05:55 AM PST
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Targacept Makes Strategic Additions to Inflammatory Disorders Program

Licenses NNR-based Patents and Compound Library from Cornerstone

Therapeutics

Aug. 3, 2010 (Business Wire) -- Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics(TM), today announced that it has added to its program for inflammatory disorders by entering into an exclusive worldwide license agreement with Cornerstone Therapeutics Inc. The agreement grants Targacept rights to Cornerstone’s NNR-based patents, as well as its library of preclinical compounds that act on the alpha7 or other nicotinic receptors. The technology licensed from Cornerstone by Targacept arose from work done at The Feinstein Institute for Medical Research led by Kevin J. Tracey, M.D.

“The research we’ve conducted at The Feinstein Institute for Medical Research supports broad therapeutic application for drugs that target alpha7 nicotinic receptors and provides a strong scientific foundation for development of new therapies,” said Kevin J. Tracey, M.D., Director and Chief Executive of The Feinstein Institute for Medical Research. “Targacept has established itself as a leader in the development of nicotinic compounds, and I am delighted to support its efforts to bring new treatment alternatives to the millions of patients suffering from inflammatory diseases and disorders.”

“We look forward to further exploiting the unique breadth of therapeutic applications for NNRs by expanding our work in promising indications where inflammation is a key component,” said J. Donald deBethizy, Targacept’s President and Chief Executive Officer. “We believe that NNR Therapeutics hold significant promise in treating a wide variety of inflammatory disorders and are especially enthusiastic about compounds selective for the alpha7 nicotinic receptor. This strategic transaction enhances our inflammatory disorders program and further bolsters our industry-leading NNR-based patent estate.”

Under the terms of the agreement, Targacept will make an upfront payment of $1.5 million to Cornerstone and Cornerstone will be eligible for additional payments from Targacept contingent upon achievement of specified milestones, as well as royalties on any future net sales of products covered by the licensed patents in the low single digits or, to the extent any internal Targacept compound for inflammatory disorders is covered by a licensed patent, below one percent.

Inflammation is a physiological response to pathogens and tissue damage in which cytokines are released to limit infection and promote tissue repair, a process modulated through the cholinergic anti-inflammatory pathway. This pathway is composed of the vagus nerve, the neurotransmitter acetylcholine and the alpha7 nicotinic receptor. Inflammatory diseases such as asthma, inflammatory bowel disease, rheumatoid arthritis, sepsis, Type 2 diabetes and ulcerative colitis may be the result of excessive cytokine production, which may be modulated through targeting the alpha7 receptor. Alpha7 agonists have shown effectiveness in a variety of preclinical models of inflammation, suggesting their potential utility in treating diseases with inflammatory components [1].

About Targacept

Targacept is developing a diverse pipeline of innovative NNR Therapeutics™ for difficult-to-treat diseases and disorders of the nervous system. NNR Therapeutics selectively modulate the activity of specific neuronal nicotinic receptors, a unique class of proteins that regulate vital biological functions that are impaired in various disease states. Targacept’s lead program, TC-5214, is in Phase 3 development as an adjunct treatment for major depressive disorder. Targacept leverages its scientific leadership and proprietary drug discovery platform Pentad™ to generate novel small molecule product candidates to fuel its pipeline and to attract significant collaborations with global pharmaceutical companies. Targacept is committed to Building Health and Restoring Independence™ for patients. For more information, please visit www.targacept.com.

Forward-Looking Statements

This press release includes “forward-looking statements” made under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements other than statements of historical fact regarding, without limitation: the utility or benefits of agonists of the alpha7 nicotinic receptor or other NNR Therapeutics in the treatment of inflammatory diseases and disorders; any payments that Targacept may make to Cornerstone Therapeutics Inc.; or Targacept’s plans, expectations or future operations, financial position, revenues, costs or expenses. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various important factors, including without limitation risks and uncertainties relating to: the conduct and results of non-clinical studies and assessments and clinical trials of compounds covered by the patents licensed by Targacept, including the performance of third parties engaged to execute such trials, studies and assessments, delays resulting from any changes to the applicable protocols and difficulties or delays in the completion of subject enrollment or data analysis; Targacept’s ability to protect its intellectual property; and the timing and success of submission, acceptance and approval of regulatory filings. These and other risks and uncertainties are described in greater detail under the heading “Risk Factors” in Targacept’s most recent Annual Report on Form 10-K and in other filings that it makes with the Securities and Exchange Commission. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Targacept cautions you not to place undue reliance on any forward-looking statement.

In addition, any forward-looking statement in this press release represents Targacept’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Targacept disclaims any obligation to update any forward-looking statement, except as required by applicable law.

NNR Therapeutics™ is a trademark of Targacept, Inc. Any other service marks, trademarks and trade names appearing in this press release are the properties of their respective owners.

[1] Rosas-Ballina M, Tracey KJ. Cholinergic control of inflammation. J. Internal Med 2009; 265: 663-679.